Study of Telaprevir in Subjects With Hepatic Impairment

Completed · Phase 1

Conditions studied: Hepatic Insufficiency

In brief

The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.

Key facts

Study ID

NCT00509210

Run by

Vertex Pharmaceuticals Incorporated

Starts

2007-09-01

Expected to finish

2008-06-01

Last updated by the study team

2008-10-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinically diagnosed with Child Pugh score of 7-9 or greater than 10
• Women of non-childbearing age

You may not qualify if…

• Tested positive for HIV, Hepatitis C, Hepatitis B

Where it is running

• Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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